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NCT01164124 · ClinicalTrials.gov registry record · Phase 2

Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

A Phase 2 study, sponsored by Vermont Oxford Network.

Completed
Registry status
Phase 2
Development phase
101
Enrollment target

NCT01164124: Completed Phase 2 study, sponsored by Vermont Oxford Network.

NCT01164124 is a Phase 2 study that has completed, run by Vermont Oxford Network. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01164124, a Phase 2 study, has completed, sponsored by Vermont Oxford Network.

COMPLETED
Registry status
Phase 2
Development phase
101 participants
Enrollment target

Study Summary

The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and achieve better weight gain.

Primary Outcome

Percentage of infants with weight less than the 10th percentile at 34 weeks postmenstrual age.

Interventions

  • OTHER Placebo
  • DIETARY_SUPPLEMENT Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis)

Trial Details

FieldValue
Enrollment Target 101 participants
Start Date 2008-02
Est. Completion 2009-08
Phase Phase 2
Vermont Oxford Network

3 total trials

What the finished NCT01164124 record still lists

NCT01164124 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01164124 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01164124 about?

NCT01164124 is a clinical study titled "Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants". The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and achieve better weight gain.

What is the current status of trial NCT01164124?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2008-02. Estimated completion is 2009-08.

What interventions are being tested in trial NCT01164124?

The interventions under investigation include: Placebo (OTHER), Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis) (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01164124?

This trial is sponsored by Vermont Oxford Network, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01164124's enrollment target sits among peer trials

101 672nd of 2000 higher than 1,329 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01164124, the US trial registry maintained by the National Library of Medicine. NCT01164124 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.